Adult BCG Vaccination vaccination of adults.pptx

Adult bcg

1. Orientation to A dult BCG V accination S tudy P rotocol

2. History Tuberculosis was a major cause of morbidity and mortality. In May 1948  Government of India decided to introduce BCG vaccination on a limited scale and under strict supervision  measure to control the disease. A BCG Vaccine Laboratory at King Institute, Guindy , Madras (Chennai), Tamil Nadu, was set up in 1948. In 1951 representatives of the State Government  a proposal  extension of mass BCG Vaccination Campaign throughout India. The efficacy of BCG vaccine in prevention of pulmonary TB was in questions, since the very beginning.

3. A large BCG trial named ‘Feasibility Study for TB Prevention Trial’ was conducted in Chingelput , Tamil Nadu. This trial was started in 1968, recruitment and fifteen year follow up for all cases was completed by 1987. The trial showed that BCG vaccination did not offer significant protection against TB of the lung which occurs mostly in adults. In India BCG vaccination policy was revised and it was recommended to be given at an early age preferably before the end of the first year after birth by integrating under UIP.

4. Why in adults? Recent evidence and experience from various countries following a revaccination policy has demonstrated  the effectiveness of BCG vaccination for individuals of higher age groups. Re-analysis of the Chingleput trial indicated that the BCG vaccination in a community offered modest protection with  36% efficacy  against the development of TB disease at the end of  15 years.   Another study too among adults in India cited BCG revaccination to be  immunogenic.

5. Rationale for Adult BCG vaccination in India End TB document (2017)    Vaccination leads to steep decline in TB incidence Licensed TB Preventive Treatment (TPT)  is currently offered to only select sub set of the population. Long treatment time and adherence  by the patients pose challenges for TPT.  WHO  17% decline per year in TB incidence can be achieved by introducing vaccine Vaccines targeted at adolescents/adults could be  cost-effective , or even  cost-saving  before 2050, if the duration of protection were 10 years or longer.

6. Inclusion Criteria 04 The target population individuals aged 18 years and above, meeting any of the following criteria: (single criteria or multiple criteria's) History of TB disease People who are reported to have at least one episode of TB in past 5 years. Close contacts of TB patients Contacts of current TB patients as well as all those contacts of index TB cases enrolled in Ni- kshay from 1st January 2021 Individuals aged 60 years or above Individuals with history of Diabetes (Self- reported). Wherever feasible, documentary evidences of diagnosis and treatment for diabetes will be obtained. Individuals with a history of smoking tobacco (Current / Past User)- self reported Individuals with a Body Mass Index of less than 18 kg per sq.mts

7. 05 Study Population : Exclusion Criteria Individual’s age < 18 years ​ Those who haven't consented or cant consent to take adult BCG vaccine​ Individuals with a known history of HIV​ Individuals with a known history of immunodeficiency or on immunosuppressive drugs or recipients of any procedure interfering with immune status or transplant or malignancy​ Pregnant or lactating women​ Currently sick due to any reason Individuals with a history of blood transfusion in last 3 months ​ History of known severe reaction to BCG or any other vaccines administered ​ ORIENTATION TO ADULT BCG VACCINATION PROTOCOL Individuals with a history leading to high-risk of getting HIV infection

8. 06 Special consideration for Adult BCG vaccination Sick and hospitalized individuals will be vaccinated after recovery and medical advise. Individuals on TB Preventive Treatment (TPT) would be vaccinated 4 weeks after completion of TPT as per NTEP guidelines. Individuals currently on ATT (Anti Tuberculosis Treatment) are NOT eligible for BCG vaccine. One can get adult BCG vaccine 4 weeks after completion of current treatment. Individuals who received adult BCG vaccine and eligible for TPT to be provided TPT only after 4 weeks post vaccination. 4 WEEKS ORIENTATION TO ADULT BCG VACCINATION PROTOCOL

9. BCG vaccination will be administered through the public health system. BCG Vaccine in adults is an intervention additional to routine activities for prevention, diagnosis and treatment of TB along with its notification of TB disease and its notification as per NTEP guidelines The written consent from eligible beneficiaries at the session site will be obtained by the vaccinator before administering the vaccine.

10. Consent will also include willingness to participate in the follow-up ie . Monthly basis for initial 3 months and later on quarterly basis for next 33 months. Acceptance of BCG vaccine is purely voluntary. All individual data to be recorded in Ni- kshay and & TBWIN.

11. 11 Monitoring Safety Evaluation field teams will be sought to constitute monitoring teams in all intervention as well as control clusters. Support from: ICMR institutes DGHS Responsibilities include: 1. Monitoring of immunization activities 2. Facilitating TB case notification as well as AEFI reporting Current AEFI surveillance operational guidelines published by the MoHFW will be used. Data on AEFIs reported, recorded and investigated will be shared with ICMR team for safety evaluation. ORIENTATION TO ADULT BCG VACCINATION PROTOCOL

12. BCG Vaccine VACCINE AND COLD CHAIN FOR ADULT BCG VACCINATION 01 BCG only diluents to be used for BCG reconstitution Freeze Dried powder Sensitive to light and heat supplied in Amber colour bottle Use only 0.1 ml AD syringe for giving vaccine to beneficiaries Reconstitution syringe, can be 2 ml , 3ml or 5ml VVM mentioned on top of the seal

13. BCG Vaccine Vaccine attribute aBCG Vaccine Type Live attenuated Dosage 0.1 ml Presentation Freeze dried VVM Type VVM 14 Doses per vial 10 doses Open Vial Policy Not applicable (Not to be used after 4 hours of reconstitution) Reconstitution Required with diluent provided Storage volume per dose 2.6 cm 3 Diluent Sodium Chloride Injection I.P. (1 ml ampoule) Storage volume per dose for diluent 1.4 cm 3 Storage Store +2° to +8 °C Route of administration Intra dermal Vaccination site Right upper arm

14. Secondary objective To determine the effectiveness of adult BCG vaccination against active tuberculosis with annual review. To determine safety of adult BCG vaccination under programmatic settings in vaccinated individuals with annual review. 1 Effect of BCG vaccination amongst vulnerable adult population on reducing TB disease: a programmatic study. Primary objective To evaluate the effectiveness of a strategy to vaccinate vulnerable individuals older than 18 years with BCG vaccine under programmatic settings on the occurrence of notified TB cases upto a period of 36 months post-intervention. Study Title Study Objectives

15. Study Settings 03 A restricted randomization process followed for the study with - 50% of the NTEP districts of the consenting State/ UT are allocated to intervention arms and rest 50% of NTEP allocated to control arm. 23 states/ UTs expressed consent for participation. Out of 547 NTEP districts - 274 are in intervention arm 273 are in comparator arm Andaman and Nicobar Islands Haryana Puducherry Punjab Rajasthan (4 Districts)* Tamil Nadu Telangana Tripura Uttar Pradesh Andhra Pradesh Himachal Pradesh Jammu & Kashmir Jharkhand Karnataka (6 Districts)* Madhya Pradesh Maharashtra Odisha Assam (2 Districts)* Chhattisgarh Dadra,  Nagar Haveli &  Daman & Diu (1 District)* Delhi Goa Gujarat Kalaburagi, Bidar , Bijapur , Bagalkot , DK & Udupi

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